Draft Research Plan

Draft Research Plan for Hepatitis C Virus Infection in Adolescents and Adults: Screening

This opportunity for public comment expired on October 18, 2017 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF.
The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

Recommendations made by the USPSTF are independent of the U.S. government.
They should not be construed as an official position of the Agency for Healthcare
Research and Quality or the U.S. Department of Health and Human Services.

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Draft: Proposed Analytic Framework

* Includes persons without abnormal laboratory values. Adolescents are defined as those ages 12 to 17 years. Excludes persons living with HIV, transplant recipients, and patients with renal failure.† Defined as HCV antibody testing with confirmatory HCV RNA testing as indicated.‡ Includes interventions that may affect vertical transmission of HCV, such as cesarean delivery, amniocentesis, and fetal monitoring, as well as antiviral treatment.

Draft: Proposed Key Questions to Be Systematically Reviewed

1a. Does screening for hepatitis C virus (HCV) infection in pregnant and nonpregnant adolescents and adults without known abnormal liver enzyme levels reduce HCV-related mortality and morbidity or affect quality of life?
1b. Does prenatal screening for HCV infection reduce risk of vertical transmission of HCV infection?
2. What is the effectiveness of different risk- or prevalence-based methods for screening for HCV infection on clinical outcomes?
3. What are the harms of screening for HCV infection (e.g., anxiety and labeling)?
4. What are the effects of interventions during labor and delivery or the perinatal period on risk of vertical transmission of HCV infection?
5. What is the effectiveness of currently recommended antiviral treatments in improving health outcomes in patients with HCV infection?*
6. What is the effectiveness of currently recommended antiviral treatments in achieving a sustained virologic response?*
7. What are the harms of currently recommended antiviral treatments?*
8. What is the association between improvement of sustained virologic response following antiviral treatment and reduction in risk of HCV-related adverse health outcomes?

Draft: Proposed Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

Based on population level estimates, what are recent trends in the epidemiology, prevalence, and incidence of HCV infection in the United States over the past 5 to 10 years?

What are the effects of different risk- or prevalence-based methods for screening for HCV infection in modeling studies?

What is the effect of antiviral treatments on behavioral outcomes (e.g., risky sexual or drug use behavior)?

Draft: Proposed Research Approach

The Proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the KQs.

The evidence review will focus on screening in asymptomatic persons without known liver function test abnormalities. Patients who are coinfected with hepatitis B virus or HIV will be excluded from the review since management of these conditions may include evaluation for HCV infection. Older antiviral regimens that are no longer recommended will also be excluded. For KQs related to screening, the focus will be on settings applicable to U.S. primary care. Studies of screening from specialty settings and geographic areas in which the epidemiology and management of HCV infection differ substantially from U.S. primary care settings will be excluded.

Persons with screen-detected or asymptomatic HCV infection (patients with a METAVIR fibrosis score of 0–2, if symptom status is not reported); persons with no prior antiviral treatment; includes pregnant women

Persons who are coinfected with HIV or hepatitis B virus, transplant patients, persons with renal failure

Interventions

Currently recommended direct-acting antiviral regimens

Interferon-based treatment and other nonrecommended regimens

Comparisons

Another direct-acting antiviral regimen or older antiviral regimen; includes clinical trials without a comparison group